NDC 0024-5843

Leukine

Sargramostim

Leukine is a Intravenous; Subcutaneous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Sargramostim.

• Product ID: 0024-5843_ac281296-b49b-4f33-a16c-a83e60964713
• NDC: 0024-5843
• Product Type: Human Prescription Drug
• Proprietary Name: Leukine
• Generic Name: Sargramostim
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 1991-05-01
• Marketing End Date: 2021-12-30
• Marketing Category: BLA / BLA
• Application Number: BLA103362
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: SARGRAMOSTIM
• Active Ingredient Strength: 250 ug/mL
• Pharm Classes: Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 0024-5843-05

5 VIAL in 1 CARTON (0024-5843-05) > 1 mL in 1 VIAL (0024-5843-01)

• Marketing Start Date: 1991-05-01
• Marketing End Date: 2021-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5843-01 [00024584301]

Leukine INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103362
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-11-05
• Marketing End Date: 2021-12-30

NDC 0024-5843-05 [00024584305]

Leukine INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103362
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1991-05-01
• Marketing End Date: 2021-12-30

Drug Details

Active Ingredients

Ingredient	Strength
SARGRAMOSTIM	250 ug/mL

OpenFDA Data

• SPL SET ID: 04765fbf-f005-43aa-a628-5cc3d80f91e7
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • 5TAA004E22
• RxNorm Concept Unique ID - RxCUI:
  • 312903
  • 208083
  • 213395
  • 315199

Pharmacological Class

• Granulocyte Colony-Stimulating Factor [CS]
• Granulocyte-Macrophage Colony-Stimulating Factor [CS]
• Increased Myeloid Cell Production [PE]
• Leukocyte Growth Factor [EPC]
• Granulocyte Colony-Stimulating Factor [CS]
• Granulocyte-Macrophage Colony-Stimulating Factor [CS]
• Increased Myeloid Cell Production [PE]
• Leukocyte Growth Factor [EPC]

NDC Crossover Matching brand name "Leukine" or generic name "Sargramostim"

NDC	Brand Name	Generic Name
0024-5843	Leukine	SARGRAMOSTIM
0024-5844	Leukine	SARGRAMOSTIM
71837-5843	Leukine	SARGRAMOSTIM
71837-5844	Leukine	SARGRAMOSTIM